Boys Up Next for HPV Vaccine Gardasil?

It’s been a bit of a hard sell for the pharmaceutical companies to convince parents that their preteen daughters ought to get vaccinated against HPV, the human papilloma virus known to cause cervical cancer and genital warts.

Some conservatives worry the vaccine could encourage early sexual activity. Others lament the vaccine’s high cost –typically $360 for the required three doses-- and a few critics question its safety.

Still, marketing strategies and strong support from pediatricians and the U.S. Food and Drug Administration have paid off. Nearly 25% percent of young women between 13 to 17 years old received the HPV vaccine Gardasil in 2007 the year after its launch, according to the Centers for Disease Control and Prevention.

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"In general, we're quite pleased with the results at 25 percent. But it points out that we've got a long ways to go." says Dr. Lance Rodewald, head of the CDC's division of immunization services.

Now Merck and Co., the drug maker that sells the vaccine in the U.S., is seeking federal approval to market Gardisil to boys. The logic behind the request is that vaccinating young boys against the human papilloma virus will help stop its sexual transmission to young women and more effectively eradicate cervical cancer.

Merck also points to a recent study of about 4,000 young males ages 16 to 26 that showed Gardisil prevented not just genital warts but also penile cancer, a more rare disease also linked to certain strains of HPV.

The FDA will review Merck’s application and a decision could be made as early as 2010. The vaccine has already been approved for boys in Australia, Mexico and several European countries.

Should Gardasil continue to prove effective in young men, widening its use to both sexes “is the correct way to try and do things,” states Michael Bookman, M.D., director of medical gynecologic oncology at Fox Chase Cancer Center in Philadelphia in a Healthday article. “I think that the best way of controlling (cervical cancer) with a vaccine is to use it broadly.”